Clinical Basics: eTMF is a cloud-based electronic trial master file system that enables organizations to efficiently manage their clinical trials. With full support for the latest versions of the TMF Reference Model, Clinical Basics: eTMF gives sponsors and CROs real-time access to clinical documentation at every point in a trial’s set-up, execution, and archival.
eTMF Features
Clinical Basics: eTMF provides a pre-configured environment for managing an electronic trial master file. This Vault consists of two main areas:
- Clinical Admin
- TMF Workspace
You will use the Tab Collections menu to toggle between these areas as necessary to complete your tasks. In addition to the tabs, there is also a Create button. The functionality of Create varies depending on the tab you have selected.
Clinical Admin
When you launch the Clinical Basics: eTMF application, the system automatically displays the Clinical Admin Window.This window includes these tabs:
- Studies: allows creation and management of studies
- Quality Issues: allows management of quality issues for TMF documents
- Global Directory: allows management of organizations and personnel
- Products: allows management of available products in Vault
- Reports: provides a set of pre-defined reports and dashboards that end-users can view.
- Users: allows management of access to available studies in Vault
- Loader: allows you to load data to your Vault or extract data from your Vault in bulk.
- Help: allows access to Vault Basics Help
TMF Workspace
To access the TMF workspace, select it from the Tab collections drop-down.This window includes these tabs:
- Home: allows users to view all tasks and workflows associated with their user profile
- Library: allows users to create a customized view of all items in their Vault Clinical Library
- TMF Viewer: allows staff and inspectors to navigate the TMF in TMF RM v3.0 format
- Reports: allows users to view a set of pre: defined reports and dashboards t
- TMF Archive: allows users to view a list of all documents that have been archived
- Help: allows access to Vault Basics Help